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Not Yet Recruiting NCT05743608

NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients

Conditions: COPD

Sex: All
Ages: 35 Years – N/A
Enrollment: 1000
Sponsor: Chiesi Hungary Ltd.

Location: Hungary

Summary

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question[s] it aims to answer are:Treatment's effect on quality of lifeTreatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.

Eligibility Criteria

Inclusion criteria:Patient had been diagnosed with COPD for over a year by a pulmonologists specialistPatients ≥ 35 years of ageoutpatientHaving had a spirometry test performed maximum 1 month prior to inclusion OR on the day of study inclusionEligibility to Trimbow 88/5/9 µg inhalation powder treatment according to SmPC:having a moderate or severe obstruction (30%≤FEV1<80%)uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA):at least 1 severe or 2 moderate exacerbations (requiring hospital admission) in the past 12 monthssymptomatic patient (CAT≥10 and/or mMRC ≥2)Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to or on the day of study inclusion and irrespective of study entry (escalation of symptomatic patient to fixed triple combination as per treatment protocol)Patient provided informed consent to study participation and related data collectedPatient with no functional disabilityExclusion criteria:Participation in any clinical trial, 30 days prior to inclusionOngoing severe exacerbation (requiring hospitalisation) or severe exacerbation within the last 4 weeksDiagnosis of asthma (asthma/COPD co-occurrence - ACO not allowed!)Continuous use of oral corticosteroids or oxygen therapyPatients with other important diseases of the respiratory system or other organ systems that may significantly contribute to COPD symptoms (such as untreated heart failure, symptomatic anaemia, etc.)Any additional contraindications listed in the SmPC for Trimbow® 88/5/9 µg inhalation powder and any other provision in the SmPC that would prevent the patient from receiving fixed triple combination therapyThe patient is unable to complete the part of the questionnaire(s) relevant to him/her

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05743608). StuddyBuddy aggregates publicly available trial information.